Overview

Sometimes, a drug product is classified as a Generic- OTC in one country and the same is recognized as a Generic- Prescription by another country. At such times a company cannot afford any misinterpretation, and hence they are required to have necessary knowledge before proceeding to business expansion. Whether it is decoding dossier requirements or import regulations for their drug products, a pharma company must be aware of all the necessary geo-specific requirements. A proactive approach and comprehensive drug Regulatory intelligence (RI) to acquire a comprehensive overview of the Regulatory landscape of the targeted country is the need of the hour for drug makers and sellers.

Freyr’s drug Regulatory intelligence (RI) team understands the importance of required Regulatory information, and how accurate should it be for a successful market-entry. Starting from addressing any focused Regulatory query, overview of targeted country’s regulations or to assess the Regulatory needs prior to product registration, Freyr tailors its RI solution for drug category to meet diverse needs of global pharmaceutical and biopharmaceutical companies. To provide RI in a streamlined manner, Freyr has divided drug product category as:

  • New Chemical Entity / New Molecule Entity (NCE/NME)
  • Generic- Prescription
  • Generic- OTC
  • Biologics
  • Biosimilar
  • Vaccines
  • Orphan Drug
  • Traditional Medicine
 

Freyr Expertise

  • Regulatory overview of targeted country
  • Product categorization & classification
  • Registration requirements
  • Drug labeling support for translations
  • Packaging requirements
  • Clinical study requirements
  • GxP requirements
  • Import regulations
  • Local agent requirement
  • Post marketing authorization
 

Freyr Advantages

  • Skilled and experienced drug Regulatory intelligence professionals
  • Proven expertise in:
    • Regulatory analysis and assessment
    • Regulatory report writing
    • Regulatory secondary research
    • Regulatory primary research